Identity
- Trade Name
- Dorma 200 with Humidifier, FR EUDAMEDDorma 200 FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- REMstar, REMstar SE, Dorma EUDAMEDDorma 200 with Humidifier, France FDA UDI
- Model / Reference
- FRV201H EUDAMEDDorma 200 with Humidifier, FR FDA UDI
- Description
- Dorma 200 with Humidifier, France FDA UDI
Identifiers
- Catalog Number
- FRV201H FDA UDI
- Primary DI / UDI-DI
- 00606959036802 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959036802 EUDAMED
- 510(k) Number
- K130077 FDA UDI
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z1203010502 ADULT PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Home CPAP unit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dorma 200 with Humidifier, FR by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959036802 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 7cd1b3fd-2501-4276-a07e-5f79afdcd861 61 fields · synced Jun 19, 2026
- FDA UDI 0be9062c-652a-486a-b763-4796962b11ec 37 fields · synced May 30, 2026
- EUDAMED 1e6a1710-736d-47a6-8863-0cac3ecf4a7a 61 fields · synced Jun 19, 2026